TABLE 2.
Summary of omadacycline PK parameters in ESRD and healthy subjectsa
| Subject | AUC0–last (μg · h/ml) | AUC0–inf (μg · h/ml) | Cmax (μg/ml) | Tmax (h) | t1/2 (h) | CL (liters/h) | Vss (liters) |
|---|---|---|---|---|---|---|---|
| ESRD subjects n = 8 | |||||||
| Dosing after hemodialysis | 9.40 (2.10) | 10.30 (2.35) | 1.88 (0.74) | 0.58 (0.58, 1.08) | 18.6 (5.21) | 10.1 (2.24) | 214 (56.1) |
| Dosing before hemodialysis | 9.25 (1.80) | 10.20 (1.99) | 2.33 (1.02) | 0.59 (0.58, 0.77) | 18.9 (6.34) | 10.1 (2.05) | 194 (69.2) |
| Healthy subjects n = 8 | 9.08 (1.86) | 9.76 (1.77) | 1.92 (0.41) | 0.58 (0.58, 0.68) | 17.1 (2.60) | 10.6 (1.99) | 204 (47.6) |
a
The arithmetic mean (standard deviation) is shown for all parameters except Tmax, where the median (range [minimum, maximum]) are shown. AUC0–last, area under the concentration-time curve from time zero to the last quantifiable concentration in plasma; AUC0–inf, area under the concentration-time curve from time zero extrapolated to infinity in plasma; Cmax, maximum observed concentration of omadacycline in plasma; CL, total body clearance; ESRD, end-stage renal disease; PK, pharmacokinetics; t1/2, terminal elimination half-life in plasma; Tmax, time of the maximum observed plasma omadacycline concentration; Vss, volume of distribution at steady state.